- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06761326
Right Versus Left Distal Axillary Vein Cannulation
Right Versus Left Ultrasound-Guided Distal Axillary Vein Cannulation : A Prospective Randomized Study
Central venous cannulation is an essential procedure in the anaesthetic and critical care practice. Ultrasound has revolutionized the practice favoring the internal jugular cannulation to the other sites .Subcalvian vein cannulation has fallen out of favor mainly due to the difficult visualization with the ultrasound, especially in obese patients and the inevitable position of the clavicle acting as a bony obstacle , in addition to the anatomical position in vicinity to the pleura which might raise the risk of pneumothorax . Indeed the subclavian vein cannulation is more comfortable and tolerated by the patient especially those requiring long term intravenous therapy, with less rates of infection and thrombosis. This mandated the development of a safer and efficient technique for the cannulation empowered by the ultrasound technology.
The infracalvicular approach or the proximal axillary vein cannulation has been described but is not popular. It provides a potentially safer and successful technique with less complication both in "experienced" and "less experienced"operators . All the patients will receive general anaesthesia with laryngeal mask insertion . Careful sterilization of the surgical site and strict aseptic techniques for the handling of the ultrasound probe will be pursued
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Engi y Hashem, MD
- Phone Number: 0201223372319
- Email: engi.hashem@alex-mri.edu.eg
Study Contact Backup
- Name: Wessam Z ElAmrawy, MD
- Phone Number: 0201280998606
- Email: Wesam.amrawy@alex.edu.eg
Study Locations
-
-
Alexandria Governorate
-
Alexandria, Alexandria Governorate, Egypt, 21561
- Recruiting
- Medical Research Institute
-
Contact:
- khaled Matarawy, MD
- Phone Number: 02034282331
- Email: mri-dean@alexu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
.Patients requiring porta Cath insertion.
Exclusion Criteria:
- Abnormalities in the platelet count or coagulation
- Thrombosis of the target vein
- Soft tissue infection of the overlying area
- Fracture of the clavicle or proximal ribs
- Patients with pacemakers or defibrillators
- Malignant superior vena cava syndrome
- Gross obesity
- History of prior catheterization of the subclavian vein
- Patient refusal to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Right subclavian vein cannulation
All patients will be in supine position, with the right arm abducted to 45 degrees , the angle of the arm will be increased to 90 degrees to best acquire the image.
The probe will be placed in he parasagittal plane in the deltopectoral groove of the right side , medial to the coracoid process .
The image will be optimized for the best image of the right axillary artery and vein similar to that acquired when performing an infraclavicular approach for brachial plexus block .
The probe will be rotated to obtain a longitudinal image of the right axillary vein .
The needle will be introduced in real time imaging , in an in plane technique and blood will be aspirated , the guidewire will be introduced in real time imaging.
The internal jugular vein will be scanned bilaterally via ultrasonography to exclude malposition of the guidewire and will be reported in case of such.
The catheter will be introduced through the sheath and will be tunneled the skin.
|
All patients will be in supine position, with the arm abducted to 45 degrees , the angle of the arm will be increased to 90 degrees to best acquire the image.The probe will be placed in he parasgittal plane in the deltopectoral groove medial to the coracoid process .
The image will be optimized regarding the depth , focus and the gain accorgingly for the best image of the axillary artery and vein similar to that acquired when performing an infraclavicular approach for brachial plexus block .
The probe will be rotated to obtain a longitudinal image of the axillary vein .
The needle will be introduced in real time imaging , in an inplane technique and blood will be aspirated , the guidewire will be introduced in real time imaging.The internal jugular vein will be scanned bilaterally via ultrasonography to exclude malposition of the guidewire and will be reported in case of such.
The catheter will be introduced through the sheath and will be tunneled the skin.
|
|
Experimental: Left subclavian vein cannulation
All patients will be in supine position, with the left arm abducted to 45 degrees , the angle of the arm will be increased to 90 degrees to best acquire the image.
The probe will be placed in he parasagittal plane in the left deltopectoral groove medial to the coracoid process .
The image will be optimized regarding the depth , focus and the gain accordingly for the best image of the axillary artery and vein similar to that acquired when performing an infraclavicular approach for brachial plexus block .
The probe will be rotated to obtain a longitudinal image of the left axillary vein .
The needle will be introduced in real time imaging , in an in plane technique and blood will be aspirated , the guidewire will be introduced in real time imaging.
The internal jugular vein will be scanned bilaterally via ultrasonography to exclude malposition of the guidewire and will be reported in case of such.
The catheter will be introduced through the sheath and will be tunneled the skin.
|
All patients will be in supine position, with the arm abducted to 45 degrees , the angle of the arm will be increased to 90 degrees to best acquire the image.The probe will be placed in he parasgittal plane in the deltopectoral groove medial to the coracoid process .
The image will be optimized regarding the depth , focus and the gain accorgingly for the best image of the axillary artery and vein similar to that acquired when performing an infraclavicular approach for brachial plexus block .
The probe will be rotated to obtain a longitudinal image of the axillary vein .
The needle will be introduced in real time imaging , in an inplane technique and blood will be aspirated , the guidewire will be introduced in real time imaging.The internal jugular vein will be scanned bilaterally via ultrasonography to exclude malposition of the guidewire and will be reported in case of such.
The catheter will be introduced through the sheath and will be tunneled the skin.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Successful cannulation
Time Frame: Directly after the end of the procedure
|
Recognition of the catheter in the SVC by fluoroscopy
|
Directly after the end of the procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of malposition identified by the ultrasound
Time Frame: Directly after the insertion of the guidewire and the catheter
|
The ultrasound probe will be positioned on the internal jugular vein for the recognition of malposition of the guidewire
|
Directly after the insertion of the guidewire and the catheter
|
|
Complication of the procedures
Time Frame: Directly at the end of the procedure
|
All the complications will be recognized and reported
|
Directly at the end of the procedure
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Engi Y Hashem, MD, Medical research institute , Alexandria university
Publications and helpful links
General Publications
- Kim YJ, Ma S, Yoon HK, Lee HC, Park HP, Oh H. Supraclavicular versus infraclavicular approach for ultrasound-guided right subclavian venous catheterisation: a randomised controlled non-inferiority trial. Anaesthesia. 2022 Jan;77(1):59-65. doi: 10.1111/anae.15525. Epub 2021 Jul 6.
- Imai E, Watanabe J, Okano H, Yokozuka M. Efficacy and safety of supraclavicular versus infraclavicular approach for subclavian vein catheterisation: An updated systematic review and meta-analysis of randomised controlled trials. Indian J Anaesth. 2023 Jun;67(6):486-496. doi: 10.4103/ija.ija_837_22. Epub 2023 Jun 14.
- Hosur Ravikumar R, Majage S, Prasanna M, Ray BR. Comparison of ultrasound guided supraclavicular subclavian vein versus infraclavicular subclavian/axillary vein catheterization: A systematic review and meta analysis. J Vasc Access. 2025 Mar;26(2):633-640. doi: 10.1177/11297298241239092. Epub 2024 Mar 20.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Axillary vein cannulation
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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